Brief Title
Arrhythmia Prediction Trial
Official Title
Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.
Brief Summary
Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden Cardiac Death Prediction.
Detailed Description
Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification markers is of high importance. In this study, heart failure patients will be risk stratified with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF), indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion, QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from the Autonomic Nervous System function [ Heart Rate variability, Heart rate Turbulence, Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of Heart Rate Dynamics], the Non sustained ventricular tachycardia and Ventricular extrasystolic activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring. Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG recordings will performed for further indices research and development. All the Arrhythmic Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction and for Total Mortality will be estimated according the follow up.
Study Type
Observational
Primary Outcome
Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death
Secondary Outcome
Total Mortality
Condition
Myocardial Infarction
Study Arms / Comparison Groups
SCD possitive versus SCD negative group
Description: The total Heart Failure patients subgroup experiencing Sudden Cardiac Death surrogate end-points during follow up versus the patients subgroup that is free from Sudden Cardiac Death surrogate end-points.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
500
Start Date
October 2007
Completion Date
June 2019
Primary Completion Date
June 2019
Eligibility Criteria
Inclusion Criteria: - Myocardial Infarction - Dilated Cardiomyopathy - Sinus rhythm Exclusion Criteria: - Malignant diseases seriously affecting the survival - Conditions/diseases affecting the Autonomic Nervous System's function - Dementia - Alcoholism - Psychiatric diseases - Addiction
Gender
All
Ages
20 Years - 82 Years
Accepts Healthy Volunteers
No
Contacts
Petros Arsenos, MD, PhD, 00306974338896, [email protected]
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT02175836
Organization ID
17/25-10-2006
Secondary IDs
APRET, Athens Medical School
Responsible Party
Principal Investigator
Study Sponsor
University of Athens
Study Sponsor
Petros Arsenos, MD, PhD, Principal Investigator, First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece
Verification Date
January 2016